EFFECT OF LIGHT REDUCTION ON RETINOPATHY OF PREMATURITY

这是三个相互关联的财务支持申请之一 计划涉及视网膜病变的多方案临床流行病学研究 早产儿(ROP)。这项拟议的临床试验的目标是 探讨光照减少对早产儿视网膜病变的影响。这 申请是为了支持所需的详细规划阶段： 。制定一份详细的程序手册 。招募临床中心 。文件招聘潜力 。执行研究的试点阶段，以完善程序和 表格 。为临床试验阶段准备拨款申请。 在2000年，ROP是导致失明和严重视力障碍的原因 美国每年都有婴儿出生。尽管NEI支持低温- ROP研究表明，冷冻治疗可以减少不良反应的发生率 严重ROP的结局，冷冻治疗是一种破坏性的、阻断性的 在其他情况下可能导致永久性视力缺陷的治疗 治疗成功。因此，对ROP的预防性治疗将会 预防与疾病或治疗相关的视力丧失 比任何目前可用的治疗方式更可取。 有证据表明，现代社会中光线的强度 新生儿托儿所可能是影响ROP发生的因素之一。 拟议的随机、前瞻性临床试验将检验 减少对早产儿眼睛的光照将防止或 减少中度ROP的发生率。这项研究还将开发方法 监测新生儿托儿所的光照水平。如果光线减少 已被证明有利于降低中度ROP的发生率，然后 将开发一种实用的婴儿/光衰减技术。

This is one of three interrelated applications for financial support to plan multi-protocol clinical-epidemiologic research involving retinopathy of prematurity (ROP). The objective of this proposed clinical trial is to study the effects of light reduction on retinopathy of prematurity. This application is for support of the detailed planning phase necessary to: . Develop a detailed manual of procedures . Recruit clinical centers . Document recruitment potential . Perform a pilot phase of the study in order to refine procedures and forms . Prepare a grant application for the clinical trial phase. ROP is a cause of blindness and significant visual impairment in over 2000 infants in the United States each year. Although the NEI supported CRYO- ROP Study showed that cryotherapy can reduce the incidence of adverse outcome from severe ROP, cryotherapy is a destructive, interdictive treatment which may cause permanent visual defects in otherwise successfully treated. Therefore a prophylactic therapy for ROP that would prevent visual loss related to either the disease or the treatment would be preferable to any currently available treatment modality. There is evidence to suggest that the intensity of the light in the modern neonatal nursery may be one of the contributing factors to ROP development. The proposed randomized, prospective clinical trail will examine whether reducing light to the eyes of prematurely born infants will prevent or reduce the incidence of moderate ROP. This study will also develop methods to monitor the light levels in the neonatal nurseries. If light reduction is proven to be beneficial in reducing the incidence of moderate ROP, then a practical technique of infant/light attenuation will be developed.